BPrinStratTTE: Causal Effects in Principal Strata Defined by Antidrug Antibodies

CRAN status

Bayesian models to estimate causal effects of biological treatments on time-to-event endpoints in clinical trials with principal strata defined by the occurrence of antidrug antibodies.


Principal stratification methodology


Bornkamp, B., Rufibach, K., Lin, J., Liu, Y., Mehrotra, D. V., Roychoudhury, S., Schmidli, H., Shentu, Y., and Wolbers, M. (2021), “Principal stratum strategy: Potential role in drug development,” Pharm Stat, 20, 737–751. https://doi.org/10.1002/pst.2104.

Frangakis, C. E., and Rubin, D. B. (2002), “Principal stratification in causal inference,” Biometrics, 58, 21–29. https://doi.org/10.1111/j.0006-341x.2002.00021.x.

Imbens, G. W., and Rubin, D. B. (1997), “Bayesian Inference for Causal Effects in Randomized Experiments with Noncompliance,” Ann Stat, 25, 305–327. https://doi.org/10.1214/aos/1034276631.

International Council for Harmonisation (ICH) (2020), “ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials.” https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf.

Lipkovich, I., Ratitch, B., Qu, Y., Zhang, X., Shan, M., and Mallinckrodt, C. (2022), “Using principal stratification in analysis of clinical trials,” Stat Med, 41, 3837–387. https://doi.org/10.1002/sim.9439.


The current stable version of the package can be installed from CRAN with:


The development version of the package can be installed from GitHub with:

if (!require("remotes")) {install.packages("remotes")}